Development

PMI Bio provides services to support the pharmaceutical development of new formulations or optimize existing formulations. We strive to identify product complexities in order to provide cost-effective developmental work for your compounds. Our capabilities include pre-formulation, excipient and formulation studies of parenteral, oral, topical, and lyophilized formulations, and vehicle delivery studies for poorly water-soluble APIs (e.g.: emulsions or suspension).

We design formulation studies with attention to the details, from the use of ingredients, to identification of potential stability problems, compatibility with container/closure systems, and stability of the API under the conditions of pharmaceutical manufacturing.

Whether starting from scratch or optimizing a client provided method, we create solutions customized to your needs and support that method during each step of the drug approval process. Using compendial or non-compendial methods, we test your product from the raw materials phase to the finished product/end phase.

Capabilities:

Develop new analytical methods and define a starting point for analytical lifecycle management

Establishment of product and process specific methods to support process development

Development of additional characterization methods for reference standards, etc.

Our highly skilled team works to provide the process solutions to meet your needs by supporting process changes and scale up as products progress through clinical trial phases. We strive to develop robust processes which consistently produce high-quality products on time every time. Our core competencies include but are not limited to manufacturing process design, optimization, and scale-up.